DK1154757T3 - Fast-dispersing gelatin-free dosage forms - Google Patents
Fast-dispersing gelatin-free dosage formsInfo
- Publication number
- DK1154757T3 DK1154757T3 DK00908371T DK00908371T DK1154757T3 DK 1154757 T3 DK1154757 T3 DK 1154757T3 DK 00908371 T DK00908371 T DK 00908371T DK 00908371 T DK00908371 T DK 00908371T DK 1154757 T3 DK1154757 T3 DK 1154757T3
- Authority
- DK
- Denmark
- Prior art keywords
- dosage forms
- solid dosage
- active ingredient
- gelatin
- fast
- Prior art date
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Zoology (AREA)
- Nutrition Science (AREA)
- Physiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Agricultural Chemicals And Associated Chemicals (AREA)
Abstract
The present invention relates to fast dispersing solid dosage forms that preferably dissolve in the oral cavity within sixty (60), more preferably within thirty (30), most preferably within ten (10) seconds. A novel feature of the solid dosage forms according to the invention reside in the fact that the composition is essentially free or absolutely free of mammalian gelatin. It has been discovered that the use of certain modified starches at concentrations from 20 to 90 % by weight of the solid dosage form prepares dosage forms that are mechanically and chemically stable and are able to deliver higher concentrations of an active ingredient than the heretofore utilized gelatin based fast dispersing solid dosage forms. Further, the solid dosage forms according to the invention are obtainable by removing a solvent, such as water, from a mixture comprising an active ingredient, a modified starch and a matrix forming agent via freeze drying.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
GBGB9901819.4A GB9901819D0 (en) | 1999-01-27 | 1999-01-27 | Pharmaceutical compositions |
PCT/US2000/001868 WO2000044351A1 (en) | 1999-01-27 | 2000-01-27 | Fast dispersing dosage forms free of gelatin |
Publications (1)
Publication Number | Publication Date |
---|---|
DK1154757T3 true DK1154757T3 (en) | 2008-05-13 |
Family
ID=10846608
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
DK00908371T DK1154757T3 (en) | 1999-01-27 | 2000-01-27 | Fast-dispersing gelatin-free dosage forms |
Country Status (25)
Country | Link |
---|---|
EP (1) | EP1154757B1 (en) |
JP (1) | JP4863336B2 (en) |
KR (1) | KR100852015B1 (en) |
CN (1) | CN1193740C (en) |
AT (1) | ATE382334T1 (en) |
AU (1) | AU768121B2 (en) |
BG (1) | BG65413B1 (en) |
CA (1) | CA2360647C (en) |
CY (1) | CY1107384T1 (en) |
CZ (1) | CZ301249B6 (en) |
DE (1) | DE60037653T2 (en) |
DK (1) | DK1154757T3 (en) |
ES (1) | ES2298129T3 (en) |
GB (1) | GB9901819D0 (en) |
HK (1) | HK1037536A1 (en) |
HU (1) | HU226557B1 (en) |
IL (2) | IL144412A0 (en) |
IS (1) | IS2678B (en) |
NO (1) | NO331253B1 (en) |
PL (1) | PL197462B1 (en) |
PT (1) | PT1154757E (en) |
RU (1) | RU2242968C2 (en) |
TR (1) | TR200102504T2 (en) |
WO (1) | WO2000044351A1 (en) |
ZA (1) | ZA200105930B (en) |
Families Citing this family (38)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
GB9904049D0 (en) * | 1999-02-22 | 1999-04-14 | Quadrant Holdings Cambridge | Rapidly-soluble compositions |
US7550156B2 (en) | 2001-11-23 | 2009-06-23 | Rohm And Haas Company | Optimised pellet formulations |
GB0210397D0 (en) | 2002-05-07 | 2002-06-12 | Ferring Bv | Pharmaceutical formulations |
DE60307082T4 (en) * | 2002-05-07 | 2015-04-30 | Ferring B.V. | PHARMACEUTICAL COMPOSITION WITH DESMOPRESSIN DISPERSIBLE IN THE MOUTH VALVE |
DE10237459A1 (en) * | 2002-08-16 | 2004-02-26 | Beiersdorf Ag | Cosmetic preparation containing active ingredients |
MXPA05005528A (en) * | 2002-11-26 | 2006-04-05 | Alk Abello As | Pharmaceutical allergen product. |
UA93479C2 (en) * | 2002-11-26 | 2011-02-25 | Альк-Абелло A/C | Allergen dosage form |
US8012505B2 (en) | 2003-02-28 | 2011-09-06 | Alk-Abello A/S | Dosage form having a saccharide matrix |
WO2004075875A1 (en) | 2003-02-28 | 2004-09-10 | Alk-Abello A/S | Dosage form having a saccharide matrix |
ITRM20030288A1 (en) * | 2003-06-10 | 2004-12-11 | Valerio Cioli | SUBLINGUAL ADMINISTRATION OF NON STEROID INFLAMMATORY (NSAID) |
EP2322197A2 (en) | 2003-11-10 | 2011-05-18 | Reprise Biopharmaceutics, LLC | Pharmaceutical compositions including low dosages of desmopressin |
DE20321887U1 (en) | 2003-11-10 | 2012-01-20 | Allergan, Inc. | Medicines comprising low doses of desmopressin |
EP1530967B1 (en) | 2003-11-13 | 2006-05-03 | Ferring B.V. | Blister pack and solid dosage form comprising desmopressin |
US20060210590A1 (en) | 2005-02-03 | 2006-09-21 | Alk-Abello A/S | Minor allergen control to increase safety of immunotherapy |
RU2008117396A (en) | 2005-10-04 | 2009-11-10 | Альк-Абелло А/С (Dk) | SOLID VACCINE COMPOSITION |
CN101548958B (en) * | 2008-04-03 | 2012-10-17 | 万特制药(海南)有限公司 | Dispersing tablet containing terbinafine hydrochloride |
US20100286045A1 (en) | 2008-05-21 | 2010-11-11 | Bjarke Mirner Klein | Methods comprising desmopressin |
PT2296686E (en) | 2008-05-21 | 2014-05-23 | Ferring Bv | Orodispersible desmopressin for increasing initial period of sleep undisturbed by nocturia |
US11963995B2 (en) | 2008-05-21 | 2024-04-23 | Ferring B.V. | Methods comprising desmopressin |
DE102008051579A1 (en) * | 2008-10-14 | 2010-04-15 | Rhodia Acetow Gmbh | Biodegradable plastic and use thereof |
JP5752677B2 (en) | 2009-05-19 | 2015-07-22 | セルジーン コーポレイション | Formulation of 4-amino-2- (2,6-dioxopiperidin-3-yl) isoindoline-1,3-dione |
EP2442821B1 (en) | 2009-06-18 | 2017-06-14 | Allergan, Inc. | Safe desmopressin administration |
PL2493457T3 (en) | 2009-10-30 | 2018-01-31 | Ix Biopharma Ltd | Fast dissolving solid dosage form |
US10548839B2 (en) * | 2010-03-16 | 2020-02-04 | Wei Tian | Process of manufacturing a lyophilized fast dissolving, multi-phasic dosage form |
JP5602936B2 (en) * | 2010-03-29 | 2014-10-08 | フイルメニツヒ ソシエテ アノニム | Spray-dried crystalline active ingredient |
JO3112B1 (en) | 2010-03-29 | 2017-09-20 | Ferring Bv | A fast dissolving pharmaceutical composition |
RU2566269C2 (en) | 2010-03-29 | 2015-10-20 | Ферринг Б.В. | Fast-dissolving pharmaceutical composition |
JP6061859B2 (en) * | 2010-10-08 | 2017-01-18 | アール.ピー. シェーラー テクノロジーズ エルエルシー | Oral vaccine fast-dissolving dosage form using starch |
BR112014005134A2 (en) | 2011-09-16 | 2017-04-18 | Ferring Bv | fast dissolving pharmaceutical composition |
RU2497505C1 (en) * | 2012-11-07 | 2013-11-10 | Максим Эдуардович Запольский | New therapeutic composition for treating pain syndrome accompanying smooth muscle spasm |
RU2503447C1 (en) * | 2012-11-20 | 2014-01-10 | Максим Эдуардович Запольский | Drug preparation in form of orally dispersible tablet and method for making drug preparation |
EP2952200A1 (en) | 2014-06-04 | 2015-12-09 | Alk-Abelló A/S | Allergen for prophylactic treatment of allergy |
CN106259891A (en) * | 2015-05-28 | 2017-01-04 | 上海旺旺食品集团有限公司 | A kind of probiotic bacteria buccal tablet and preparation method thereof |
RU2674765C2 (en) * | 2016-10-03 | 2018-12-13 | Михаил Лукич Ткаченко | Antifungal composition of eutectic type (options) |
FI3562486T3 (en) | 2016-12-31 | 2024-06-04 | Bioxcel Therapeutics Inc | Use of sublingual dexmedetomidine for the treatment of agitation |
SG11202012772XA (en) | 2018-06-27 | 2021-01-28 | Bioxcel Therapeutics Inc | Film formulations containing dexmedetomidine and methods of producing them |
US20240024288A1 (en) | 2019-07-19 | 2024-01-25 | Bioxcel Therapeutics, Inc. | Non-sedating dexmedetomidine treatment regimens |
US11806334B1 (en) | 2023-01-12 | 2023-11-07 | Bioxcel Therapeutics, Inc. | Non-sedating dexmedetomidine treatment regimens |
Family Cites Families (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
IE45770B1 (en) * | 1976-10-06 | 1982-11-17 | Wyeth John & Brother Ltd | Pharmaceutical dosage forms |
GB1548022A (en) * | 1976-10-06 | 1979-07-04 | Wyeth John & Brother Ltd | Pharmaceutial dosage forms |
NL8304133A (en) * | 1983-12-01 | 1985-07-01 | Unilever Nv | WATER-IN-OIL EMULSIONS CONTAINING HYDRATED STARCH GRAINS. |
DE4018247A1 (en) * | 1990-06-07 | 1991-12-12 | Lohmann Therapie Syst Lts | MANUFACTURING METHOD FOR QUICK-DISINFITTING FILM-SHAPED PHARMACEUTICAL FORMS |
DE69429119T2 (en) * | 1993-07-09 | 2002-07-18 | R.P. Scherer Corp., Troy | METHOD FOR PRODUCING FREEZER DRIED DRUG DOSAGE FORMS |
GB9401892D0 (en) * | 1994-02-01 | 1994-03-30 | Boots Co Plc | Therapeutic agents |
AU713462B2 (en) * | 1996-07-12 | 1999-12-02 | Daiichi Pharmaceutical Co., Ltd. | Quickly disintegrable compression-molded materials and process for producing the same |
JP4292588B2 (en) * | 1997-01-31 | 2009-07-08 | 日産化学工業株式会社 | Oral formulation of pyridazinone compounds |
-
1999
- 1999-01-27 GB GBGB9901819.4A patent/GB9901819D0/en not_active Ceased
-
2000
- 2000-01-27 CZ CZ20012700A patent/CZ301249B6/en not_active IP Right Cessation
- 2000-01-27 IL IL14441200A patent/IL144412A0/en active IP Right Grant
- 2000-01-27 AU AU29729/00A patent/AU768121B2/en not_active Expired
- 2000-01-27 CA CA002360647A patent/CA2360647C/en not_active Expired - Lifetime
- 2000-01-27 RU RU2001123681/15A patent/RU2242968C2/en not_active IP Right Cessation
- 2000-01-27 ES ES00908371T patent/ES2298129T3/en not_active Expired - Lifetime
- 2000-01-27 DE DE60037653T patent/DE60037653T2/en not_active Expired - Lifetime
- 2000-01-27 KR KR1020017009411A patent/KR100852015B1/en active IP Right Grant
- 2000-01-27 DK DK00908371T patent/DK1154757T3/en active
- 2000-01-27 CN CNB008031592A patent/CN1193740C/en not_active Expired - Lifetime
- 2000-01-27 EP EP00908371A patent/EP1154757B1/en not_active Expired - Lifetime
- 2000-01-27 WO PCT/US2000/001868 patent/WO2000044351A1/en active IP Right Grant
- 2000-01-27 PT PT00908371T patent/PT1154757E/en unknown
- 2000-01-27 JP JP2000595655A patent/JP4863336B2/en not_active Expired - Fee Related
- 2000-01-27 TR TR2001/02504T patent/TR200102504T2/en unknown
- 2000-01-27 AT AT00908371T patent/ATE382334T1/en active
- 2000-01-27 HU HU0105107A patent/HU226557B1/en unknown
- 2000-01-27 PL PL349666A patent/PL197462B1/en unknown
-
2001
- 2001-07-18 IL IL144412A patent/IL144412A/en not_active IP Right Cessation
- 2001-07-18 ZA ZA200105930A patent/ZA200105930B/en unknown
- 2001-07-25 IS IS6023A patent/IS2678B/en unknown
- 2001-07-26 NO NO20013679A patent/NO331253B1/en not_active IP Right Cessation
- 2001-07-26 BG BG105739A patent/BG65413B1/en unknown
- 2001-12-04 HK HK01108496A patent/HK1037536A1/en not_active IP Right Cessation
-
2008
- 2008-04-02 CY CY20081100372T patent/CY1107384T1/en unknown
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